We are seeking an experienced Automation Engineer (Project Management) to join our secondment team based in Co. Cork. In this role, you will support the successful delivery of automation projects for our client, managing the full project lifecycle from initial concept and design through to implementation, commissioning, validation, and project close-out. You will work closely with cross-functional teams, system owners, vendors, and contractors to deliver both GxP and non-GxP automation and control system projects within a regulated manufacturing environment.
Key Responsibilities:
Responsibilities include, but are not limited to:
- Perform initial feasibility assessments, concept development, and project cost estimates.
- Support and manage project-related change control activities in accordance with site procedures.
- Monitor project milestones, deliverables, and overall execution to ensure successful completion.
- Create, maintain, and oversee detailed project schedules and timelines.
- Coordinate communication and activities between internal stakeholders, external suppliers, contractors, and project teams.
- Develop User Requirements Specifications (URS) for automation projects in collaboration with system owners and business representatives.
- Work with the IT department to define and request the infrastructure required to support automation systems, including virtual environments, network hardware, and associated IT resources.
- Coordinate and manage the engagement of automation system integrators.
- Oversee automation project execution, including software development, Factory Acceptance Testing (FAT), site installation, commissioning, startup support, Site Acceptance Testing (SAT), and User Acceptance Testing (UAT).
- Prepare, review, execute, and approve validation and lifecycle documentation within the electronic document management system, including FDS, RTM, QAP, QASR, FAT, SAT, and IOQ documentation.
- Provide subject matter expertise on company automation standards, validation practices, hardware and software platforms, and associated business processes to ensure compliance and consistency across projects.
Skills & Experience:
Essential Qualifications
- Bachelor's degree in Engineering, Computer Science, or a related technical discipline.
- Minimum of three years' experience delivering automation or control systems projects within an industrial or regulated environment.
- Strong knowledge of cGMP requirements, Software Development Life Cycle (SDLC) practices, and continuous improvement methodologies such as Lean, Six Sigma, or Manufacturing Performance Systems (MPS).
- Proven project management capabilities with the ability to coordinate multiple workstreams and deliver projects successfully.
- Excellent analytical, troubleshooting, facilitation, and decision-making skills.
- Demonstrated ability to assess business needs, define technical requirements, develop business cases, and recommend practical process or technology-based solutions.
Preferred Experience
- Hands-on experience with industrial automation platforms and technologies, including Building Management Systems (BMS), PLCs, HMIs, SCADA applications, process control systems, SQL databases, and plant historian platforms.
- Familiarity with client/server architectures used in manufacturing automation environments.
- Experience with building services and facility systems such as environmental monitoring, fire detection, and access control.
- Working knowledge of regulatory requirements including 21 CFR Part 11, data integrity principles, and computerized system validation.
- Previous experience delivering automation projects within a GMP-regulated manufacturing or pharmaceutical production environment.